Medical Device Certification Specialist jobs in Ontario

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Reporting to the Director of Quality, this role is responsible for managing and coordinating the Quality Management System, as well as ensuring all final product meets Nordion’s standards and specifications. From a quality perspective, the incumbent provides quality leadership for dosimetry services, gamma irradiation systems projects and parts, Co-60 sealed source manufacturing, and all other Nordion processes in accordance with customer, regulatory and quality requirements.

This position is deemed a Nuclear Energy Worker (NEW). A Nuclear Energy Worker (NEW) is defined by the Nuclear Safety and Control Act as a person who is required, in the course of the person’s business, or occupation in connection with a nuclear substance or nuclear facility to perform duties in such circumstances that there is a reasonable probability that the person may receive a dose of radiation that is greater than the prescribed limit for the general public (1 mSv per year for the whole body).

Key Responsibilities

• Ensures Nordion meets all performance targets and regulatory obligations to support compliance and reliability of operations and manufactured products.
• Ensures Nordion’s Quality Management Systems are fully implemented and continually operate within the requirements of ISO 9001.
• Administers systems such as non-conformance, complaints, change control, deviation, and corrective action and recommends actions that meet compliance standards.
• Provides quality oversight for design, manufacturing, and installation of sealed sources and gamma irradiation systems.
• Provide quality oversight for dosimetry services to conform to ISO/IEC 17025.
• Connects with Supplier’s quality and manufacturing representatives to ensure quality of all supplied components. The incumbent leads supplier quality audits of key suppliers.
• Reviews Engineering and Manufacturing investigations of non-conformances and complaints affecting product to ensure that all applicable quality, safety, and reliability requirements have been addressed.

Qualifications

• Normally Bachelor of Science or Engineering or relevant discipline.
• 4 to 6 years’ experience in Quality Assurance, or equivalently in engineering design, development and manufacturing environment.

Skills and Competencies

• Understands manufacturing and/or engineering principles, methodologies, and standards. Understands engineering drawing practices.
• In-depth understanding of the ISO 9001 and/or ISO/IEC 17025 quality assurance standards and how they are applied. Experience with ISO 13485 or CSA N299 would be a strong asset.
• Good understanding of national and international regulations and quality standards as expected by regulators such as CNSC, US NRC, CSA, ISO and European CE mark would be an asset.

• Experience in performing or overseeing validation activities.
• Experience in performing quality audits, both internal and suppliers, would be an asset.
• As part of the Quality Assurance team, capable of building and facilitating a quality culture with all employees.
• Strong communication and interpersonal skills

Additional Requirements

Training Required: Must complete all required training and certification as a Nuclear Energy Worker.

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.